NCT03320980

RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma

Split-in-situ Resection With Radio-frequency Ablation Instead of Liver Partition on the First Stage (RALPPS) in Patients With Hilar and Intrahepatic Cholangiocarcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Moscow Clinical Scientific Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Unsatisfactory immediate outcomes of Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) in surgery of cholangiocarcinoma suggested that patients with biliary cancer should not be treated by ALPPS. Short-term results of ALPPS variants with reduced surgical trauma on the first stage in patients with cholangiocarcinoma were not yet estimated. The objective of the study was estimation of the short-term results of split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage (RALPPS) in patients with hilar (h-CCA) and intrahepatic (i-CCA) cholangiocarcinoma compared with portal vein embolization (PVE).

Detailed description

ALPPS has been recently proposed as the most effective method to induce marked and rapid hypertrophy of FLR with 95-100% completion rate of the second stage. The most common indication for ALPPS is locally advanced multiple colorectal liver metastases. Unsatisfactory immediate outcomes of ALPPS in surgery of cholangiocarcinoma (CCA) including high mortality reached 48% in patients with h-CCA suggested that patients with biliary cancer should not be treated by ALPPS. Recently reported modifications of in situ splitting (partial ALPPS, RALPPS (radio-frequency-assisted liver partition with portal vein ligation for staged hepatectomy) and ALTPS (associating liver tourniquet and right portal vein ligation for staged hepatectomy) etc) have been aimed to minimize the operating injury on the first stage, hereby reducing postoperative morbidity. The other important idea was to preserve all initial benefits of ALPPS in terms of liver hypertrophy and completeness of the second stage. To date, there is no evidence of the benefits of any new ALPPS modification over others in reducing the morbidity of procedure, particularly in patients with CCA..

Conditions

• Hilar Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	RALPPS	RALPPS: split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage and major liver resection on the second stage
PROCEDURE	portal vein embolization + major liver resection	PVE on the first stage and major liver resection on the second stage

Timeline

• Start date: 2014-09-15
• Primary completion: 2017-09-20
• Completion: 2017-10-01
• First posted: 2017-10-25
• Last updated: 2017-10-25